Aura Biosciences (AURA) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

Technology platform and mechanism of action

• Bel-sar is a virus-like drug conjugate targeting a receptor expressed early in malignant transformation, enabling use across multiple solid tumor types without changing the core particle.

• The platform allows conjugation of over 200 cytotoxic molecules per particle, offering much higher potency than traditional ADCs.

• Dual mechanism: delivers targeted cytotoxicity and induces immune activation in the tumor microenvironment.

Ocular oncology focus and clinical data

• Chose ocular oncology due to high unmet need, lack of innovation, and favorable environment for viral therapies.

• Early-stage uveal melanoma targeted to prevent metastasis and preserve vision, with 80% local cure rate and 90% vision preservation in phase 2.

• Market for early-stage ocular melanoma estimated at 11,000 patients, with 5,000 suitable for frontline therapy without systemic side effects.

• Drug applicable to four ocular tumor types, including metastases to the choroid and ocular surface cancers, with a total addressable population of 66,000.

Phase 3 study design and regulatory progress

• Phase 3 is a global, three-arm (high dose, low dose, sham) randomized study with time-to-event and composite endpoints (tumor progression and visual acuity).

• SPA agreement with FDA; only 100 patients required for registrational purposes.

• Enrollment expected to complete in 2025, BLA submission in 2026, and potential approval in 2027.

• First time study is being run in Europe, with all sites now active.